Senior Regulatory Affairs Specialist

** Position Spotlight:**
* *
* What you’ll do:

Help to develop, support, and execute regulatory strategies for all product lines
**** Key Responsibilities
*** Ensure company business plans are met by submitting regulatory applications within agreed timelines. Be able to link the impact of Regulatory activities with other departments and proactively communicate and relevant information.
* Independently write executive summaries and compile documents for submissions of all types for FDA and Health Canada.

Ensure that submissions and follow up activities are of high quality, leading to timely approvals. As the main contact for your written submissions, liaise with health authorities as needed to meet project goals.
* This may include facilitating conference calls and documenting all written correspondence and face to face meetings. Actively cultivate a good relationship with regulatory authority personnel.
* Work with the Clinical Studies and Research & Development teams to secure approval for any studies requiring an Investigational Testing Authorization or Investigational Device Exemption. Coordinate the creation of required progress reports and help ensure required reports are submitted on time. Provide basic assistance with study design to ensure the study will meet the needs of regulators and lead to a successful marketing authorization.
* Represent Regulatory on cross functional product launch teams and serve as subject matter expert and key contact.
* Manage assigned post‐approval reporting obligations in the areas of progress reports for post‐approval studies and other conditions of approval. Support post market requirements related to CAPAs or field actions. Ensure documentation is kept up to date and that applicable procedures are followed.
** Key Requirements
**** Senior Regulatory Affairs Specialist
***
* What you’ll need:

Minimum 5+ years of regulatory experience and a strong background in FDA submission writing
***
* Location:

Hybrid work environment operating out of our head office in Lone Tree, CO
**** About the role
** The role of Senior Regulatory Affairs Specialist contributes to achieving Cochlear's business outcomes by providing regulatory support and guidance to help bring innovative products to our customers and helping ensure that Cochlear is compliant with premarket and post market regulatory requirements for all medical devices. This role will work closely with colleagues based at the legal manufacturers and colleagues located in North America.

The Senior Regulatory Affairs Specialist will support, guide, and lead projects in order to meet the regional priorities.

To add value to Cochlear in this role you'll be able to meet and demonstrate the following knowledge, skills and abilities in your application and at interview:

Ideal candidate will possess an advanced degree in a scientific, technical, or engineering field5+ years regulatory experience  Thorough knowledge of Health Canada and Food and Drug Administration requirements as they relate to Class II and Class III medical devices Demonstrated analytical thinking skills to identify and resolve problems.

Demonstrated experience in the management, writing and compilation of a regulatory  addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits.  Pay Range in the United States: $120,000 - $130,000 based upon experience, as well as an annual bonus opportunity of 7.5% of base salary. Exact compensation may vary based on skills, experience, and location.

and support will continue to evolve and improve. We are by our customers’ side through the entire hearing journey, so they can experience a life full of hearing. The physical and mental demands described below are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the individual is regularly required to be in a stationary (seated/standing) position; utilize business technology for work product delivery, communicate orally and in writing with others internal or external to the organization, utilize problem solving/critical thinking skills to discern and convey information.  May be asked to occasionally transport/move up to 30 pounds, depending on the position.

Specific vision abilities required by this job include ability to adjust focus. The individual is regularly required to utilize comprehension, critical thinking, communication, problem solving, organization reasoning, relating to others and discernment of items such as product specifications, procedures and processes to customers (whether internal or external).  Influence, organization/classification of information and planning are also required.
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